Medical Writer
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Job Description
Medical Writer developing clinical trial documents for Emerald Clinical Trials, a global clinical research company. Drafting protocols, CSRs, regulatory submissions, and scientific manuscripts.
Responsibilities:
- Research, write, and edit clinical documents, including clinical study reports, clinical study protocols, clinical plan outlines, regulatory submission document sections, and scientific manuscripts
- Apply therapeutic expertise, clinical drug development knowledge, and relevant experience to support development of drugs, biologics, devices, and other products for human use
- Independently write, review, and edit routine documents such as protocols, CSRs, IBs, and scientific manuscripts
- Independently interpret non-clinical and clinical data in technical reports
- Perform literature searches and reviews
- Participate in project teams and coordinate report specifications and data analysis
- Schedule and conduct peer and team quality-control reviews for assigned projects
- Review relevant documents and interact with functional leaders and project managers to understand project timelines
- Provide writing support for more complex clinical documentation under appropriate departmental supervision
- Perform other tasks as directed by the line manager
Requirements:
- Bachelor's/Master's degree from an accredited institution in Life Sciences or Health-related Sciences
- 2–4 years of science or medical-related writing experience
- Solid background in clinical medicine or pharmaceutical sciences
- Familiarity with common medical and clinical research terminology
- Familiarity with ICH-GCP and key NMPA/FDA requirements
- Knowledge of the full clinical trial process and basic statistical principles
- Ability to independently draft moderately complex documents, including protocols, CSR drafts, and investigator brochures
- Good data interpretation skills
- Proficient in English and Chinese reading and writing
- Fluent in English reading, writing, and speaking; able to independently draft English documents and communicate with overseas clients or colleagues
- Proficient in PC-Windows and MS Word; familiar with basic document templates
- Excellent written, oral communication, and presentation skills
- Ability to manage timelines for 1–2 projects
- 1–3 years of experience in a pharmaceutical company or CRO developing drugs for human use
- Basic experience in clinical study design and protocol development/writing, including participation in protocol drafting
- Basic knowledge of regulatory submission requirements and ICH CSR writing guidelines
Benefits:
- Competitive compensation: tailored salary and benefits package reflecting skills and experience
- Hybrid or remote working arrangements, depending on location and role
- Career growth and learning opportunities
- Access to a global network of scientific leaders
- Employee wellbeing programs promoting work-life balance, health, and team connection
- Global engagement surveys
- Recognition programs
- Team-building events
- Exposure to diverse international projects and clients
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